SOUTH SAN FRANCISCO, Calif. - Quince Therapeutics, Inc. (NASDAQ: QNCX) has released data from its Phase 3 ATTeST clinical trial, indicating a favorable safety profile and a positive effect in a subset of patients with Ataxia-Telangiectasia (A-T), particularly in children aged six to nine. The study, published in The Lancet Neurology, involved 175 participants across 22 academic institutions spanning five continents.
The trial aimed to assess the safety and efficacy of EryDex, a treatment that encapsulates dexamethasone sodium phosphate in autologous erythrocytes, for patients with A-T. Results showed no serious safety concerns typically associated with chronic corticosteroid use, such as hyperglycemia or hypertension. While the primary efficacy endpoint, based on the modified International Cooperative Ataxia Rating Scale (mICARS), did not show statistical significance in the overall population, a significant reduction in neurological symptoms was observed in the per-protocol population and in the pre-specified subgroup of younger patients.
The NEAT study, a pivotal Phase 3 trial currently enrolling patients, continues to investigate the neurological effects of EryDex. Conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA), Quince aims to enroll approximately 86 patients aged six to nine and around 20 patients aged ten or older. Topline results are expected in the fourth quarter of 2025, with potential regulatory submissions in 2026, assuming positive outcomes.
A-T is a rare, inherited neurodegenerative disorder with no approved treatments to date. It is characterized by progressive neurological decline, resulting in patients often becoming wheelchair-bound by adolescence. The median lifespan for those affected is approximately 25 to 30 years.
Quince Therapeutics, a late-stage biotech company focused on rare diseases, is leveraging its proprietary Autologous Intracellular Drug Encapsulation technology for the EryDex System, aiming to mitigate adverse effects associated with chronic corticosteroid treatment.
The information in this article is based on a press release statement from Quince Therapeutics.
In other recent news, Quince Therapeutics, Inc. faces a potential delisting from The Nasdaq Global Select Market due to not meeting the minimum bid price requirement. The biopharmaceutical company has been given until December 17, 2024, to regain compliance, and if unsuccessful, may consider transferring its listing to The Nasdaq Capital Market, which offers an additional 180-day period for compliance. The company's ability to meet Nasdaq's continued listing criteria or secure an extension is uncertain.
In addition, the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Quince Therapeutics' EryDex System, a treatment for Ataxia-Telangiectasia (A-T), a rare pediatric disease. This development, based on data from a previous Phase 3 study, marks a significant regulatory milestone for the company. Quince is currently enrolling participants for a global Phase 3 NEAT clinical trial to further evaluate EryDex's neurological effects in patients with A-T.
These developments are part of recent events involving Quince Therapeutics, with the potential Nasdaq delisting and the FDA Fast Track designation for EryDex being key highlights. The company continues to explore options to address its Nasdaq noncompliance and is actively advancing its clinical trial for EryDex.
InvestingPro Insights
As Quince Therapeutics (NASDAQ: QNCX) continues to explore treatment options for Ataxia-Telangiectasia with their EryDex System, the company's financial health and stock performance provide a broader context for investors. As of the last twelve months leading up to Q1 2024, Quince Therapeutics holds a market capitalization of $23.76 million, reflecting the scale of the company in the biotech industry. Despite the challenges faced in their clinical trials, the company's balance sheet shows a position of liquidity strength, with cash reserves exceeding debt, which is an encouraging sign for stakeholders and potential investors considering the company's long-term viability.
On the performance side, the stock has experienced a significant downturn, with a price total return of -56.72% over the last year and currently trading near its 52-week low. This could suggest an entry point for investors, as the stock might be undervalued; the InvestingPro Fair Value estimation stands at $1.01, notably higher than the previous close price of $0.55. Additionally, the Relative Strength Index (RSI) indicates that the stock is in oversold territory, which might attract traders looking for a potential rebound.
Investors should be aware of the company's challenges, such as quickly burning through cash and weak gross profit margins, which are important factors to consider when evaluating the company's future prospects. Quince Therapeutics does not pay a dividend, which is common among growth-focused biotech companies reinvesting earnings into research and development.
For those looking for more detailed analysis and additional insights, InvestingPro offers a comprehensive list of 15 InvestingPro Tips for Quince Therapeutics, providing a deeper dive into the company's financial health, stock performance, and potential investment opportunities.
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